The invention relates generally to detecting prostate tumors, and more particularly, relates to reagents such as polynucleotide sequences and the polypeptide sequences encoded therein, as well as methods which utilize these sequences, which are useful for the detection, diagnosis, staging, monitoring, prognosis, prevention or treatment of diseases such as prostate cancer.
Diseases such as cancer traditionally have been diagnosed by visualization of cells in tissue sections under a microscope by highly trained personnel. Interpretation of tissue sections is subjective and diagnosis can be very difficult with the small samples typically obtained for diagnosis. Usually, it is not desirable or possible to obtain a large sample from the patient. Frequently a reliable diagnosis cannot be given; it may be that there is no positive evidence of a carcinoma, but also, no certainty that the patient is actually free from carcinoma. In some cases, additional invasive investigation then is required to establish a diagnosis.
Judgment of prognosis also often relies upon the appearance of cells when viewed under a microscope. Generally, the more abnormal-looking the cellular organization in a primary tumor, the more likely the tumor will later metastasize. The correlation, however, is by no means absolute.
Certain blood tests are available to assist the physician in diagnosis of various types of cancer. For example, Prostate Specific Antigen ("PSA") is a marker which, if present in the circulatory system in elevated levels, indicates the likelihood of prostate disease, either cancer or benign prostatic hyperplasia (BPH). Assays which test for this marker currently are available. Although we discuss PSA, other such markers are available and include but are not limited to carcinoembryonic antigen (CEA) which is a marker for adenocarcinoma and human chorionic gonadotropin (hCG) which is a marker that is useful in the diagnosis of testicular and trophoblastic tumors. Although all of these markers are helpful in diagnosing a certain type of carcinoma, elevated levels are only indicative of and not diagnostic for a certain type of cancer. Also, the effect of treatment on disease is difficult to monitor at times since the circulating levels of the markers may not reflect the actual state of disease in the patient.
It would be advantageous to provide specific methods and reagents for the diagnosis, staging, prognosis, monitoring, prevention or treatment of diseases and conditions associated with prostate tumors such as cancer or to indicate possible predisposition to these conditions. Such methods would include assaying a test sample for products of the gene. Such methods would comprise making cDNA from mRNA in the test sample, amplifying (when necessary) portions of the cDNA corresponding to the gene or a fragment thereof, and detecting the cDNA product as an indication of the presence of the cancer; or detecting translation products of the mRNAs comprising gene sequences as an indication of the presence of the disease. These reagents include polynucleotide(s), or fragment(s) thereof which may be used in diagnostic methods such as reverse transcriptasepolymerase chain reaction (RT-PCR), PCR, or hybridization assays of biopsied tissue; or proteins which are the translation products of such mRNAs; or antibodies directed against these proteins. Such assays would include methods for assaying a sample for product(s) of the gene and detecting the product(s) as an indication of prostate tumor, especially prostate cancer. Drug treatment or gene therapy for conditions or diseases associated with these detected diseases and conditions then can be based on these identified gene sequences or their expressed proteins, and efficacy of any particular therapy can be monitored using the diagnostic methods disclosed herein.